FDA Inspection
Alltech Medical Systems America IncAlltech Medical Systems America Inc – FDA Inspection, Jun 17, 2009
Record Details
This FDA Inspection record concerns Alltech Medical Systems America Inc, with an inspection on June 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 17, 2009
- Product Type
- Devices
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ID · a21d11a8-2f16-4e58-9d24-130db235e2e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 589973
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of Alltech Medical Systems America Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 21, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alltech Medical Systems America Inc
- FDA Inspection 1097831 - 2019-07-29
- FDA Inspection 827215 - 2013-03-21
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